Brand new compulsory templates for clinical trials in France

Since Monday 11 April 2022, sponsors who intend to set up clinical trials with French hospitals must use brand new versions of the previous official templates ("Convention Unique") published in 2016. CROs, pharmaceutical companies and medical device companies are concerned. The two previous versions are cancelled but contracts already signed remain in force (almost 4,000 contracts signed last year). 

The key changes in the new templates compared with the previous are mainly linked (i) to the issuing of some new regulations, in particular the CTR and the GDPR (e.g. three new clauses in the new template, plus specific clauses in the event of a subcontract), and (ii) to the increase of fees for services carried out by hospitals (e.g. EUR 102 instead of EUR 85 for medical services). There are also some changes related to biologic materials, confidentiality and electronic versions of the contract. However, many clauses are unchanged, in particular the key clauses governing IP rights and publication.

In practice, the new templates to use are now available on the Ministry of Health website: La convention unique - Ministère des Solidarités et de la Santé (solidarites-sante.gouv.fr)